Proposed Budget Doubles FDA Drug Approval Process Fees

Thursday, March 30, 2017

Under the Trump administration’s proposed budget, the U.S. Food and Drug Administration (FDA) would increase product review fees from $1 billion to $2 billion in 2018. In return for the increased fees, the proposed budget would outline measures to help accelerate the review and approval process for new drugs, but did not provide specifics regarding the measures or methods for this acceleration.

The FDA has imposed approval process fees since 1992. In 2017, the majority of the fees were collected for prescription drugs (an estimated $866 million), while $324 million were collected for generic drugs, representing nearly a quarter of the agency’s 2017 budget of $5.1 billion. Citing a constrained budget environment, the proposed budget said industries that benefit from the FDA’s approval “can and should pay for their share.”